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RecruitingInterventionalPhase 1

A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

NCT ID: NCT06179160Sponsor: Incyte CorporationLast updated: 2026-05-04

Summary

This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.

Arms & interventions

  • DrugINCB161734

    INCB161734 will be administered at protocol defined dose.

  • DrugCetuximab

    Cetuximab will be administered at protocol defined dose.

  • DrugRetifanlimab

    Retifanlimab will be administered at protocol defined dose.

  • DrugGEMNabP

    GEMNabP will be administered at protocol defined dose.

  • DrugmFOLFIRINOX

    mFOLFIRINOX will be administered at protocol defined dose.

  • DrugFOLFOX

    FOLFOX will be administered at protocol defined dose.

  • DrugFOLFIRI

    FOLFIRI will be administered at protocol defined dose.

  • DrugINCA33890

    INCA33890 will be administered at protocol defined dose.

Outcome measures

Primary

  • Number of participants with Dose Limiting Toxicities (DLTs)

    Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.

    Time frame: Up to 28 days

  • Number of participants with Treatment-emergent Adverse Events (TEAEs)

    Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab and retifanlimab.

    Time frame: Up to 2 years and 90 days

  • Number of participants with TEAEs leading to dose modification or discontinuation

    Number of participants with TEAEs leading to dose modification or discontinuation.

    Time frame: Up to 2 years and 90 days

Secondary

  • INCB161734 pharmacokinetic (PK) in Plasma

    Time frame: Up to approximately 90 days

  • Objective Response Rate (ORR)

    Time frame: Up to 2 years

  • Disease Control Response (DCR)

    Time frame: Up to 2 years

  • Duration of Response (DOR)

    Time frame: Up to 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * ≥18 years old. * Locally advanced or metastatic solid tumor with KRAS G12D mutation. * For Part 1a and Part 2 Combination Groups 1, 2, and 7: Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, declined available therapies that are known to confer clinical benefit, or no standard available treatment to improve the disease outcome. * Cohort specific requirements aas defined in the protocol. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: * Prior treatment with any KRAS G12D inhibitor * Known additional invasive malignancy within 1 year of the first dose of study drug * History of organ transplant, including allogeneic stem cell transplantation * Significant, uncontrolled medical condition * History or presence of an ECG abnormality * Inadequate organ function Other protocol-defined Inclusion/Exclusion Criteria may apply

Study locations (16)

Mayo Clinic Hospital

Phoenix, Arizona, 85054

Recruiting

Stanford University

Palo Alto, California, 94305

Recruiting

UCLA Healthcare Hematology-Oncology

Santa Monica, California, 90404

Recruiting

Sarah Cannon Research Institue At Healthone

Denver, Colorado, 80218

Recruiting

Mayo Clinic Florida

Jacksonville, Florida, 32224

Withdrawn

Florida Cancer Specialists

Sarasota, Florida, 34232

Recruiting

Florida Cancer Specialists

Sarasota, Florida, 34232

Withdrawn

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

Baltimore, Maryland, 21287

Recruiting

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting

Mayo Clinic

Rochester, Minnesota, 55905

Withdrawn

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Recruiting

Weill Cornell Medicine

New York, New York, 10021

Recruiting

Memorial Sloan Kettering Cancer Center

New York, New York, 10022

Recruiting

Jefferson University Hospitals

Philadelphia, Pennsylvania, 19107

Recruiting

Scri Oncology Partners

Nashville, Tennessee, 37203

Recruiting

Md Anderson Cancer Center

Houston, Texas, 77030

Recruiting
A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation | Cancerify